Bisoprolol in Patients With Heart Failure and Chronic Obstructive Pulmonary Disease

This study has been terminated.

(Inadequate patient recruitment)

Sponsor:

Information provided by:

NHS Greater Glasgow and Clyde

ClinicalTrials.gov Identifier:

NCT00702156

First received: June 19, 2008

Last updated: September 2, 2008

Last verified: August 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

June 19, 2008

Last Updated Date

September 2, 2008

Start Date ^ICMJE

March 2005

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Forced expiratory volume 1 second (FEV1) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00702156 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Quality of life: Minnesota Living with Heart Failure, SF-36 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
NYHA Class [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Bisoprolol in Patients With Heart Failure and Chronic Obstructive Pulmonary Disease

Official Title ^ICMJE

Cardioselective Beta-Blockade Using Bisoprolol in Patients With Chronic Heart Failure (CHF) and Coexistent Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) With or Without Significant Reversibility.

Brief Summary

The principal research objectives are to demonstrate cardioselective beta-blockade using bisoprolol is not inferior to placebo with regard to pulmonary function and improves quality of life in patients with heart failure and coexistent moderate or severe chronic obstructive pulmonary disease with or without significant reversibility. Patients will be followed up for 4 months during which bisoprolol will be up-titrated to the maximum clinically tolerated dose. Health status will be assessed using a generic and two disease specific questionnaires, and pulmonary function by spirometry, body box plethysmography, and cardiopulmonary exercise testing.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Heart Failure
Chronic Obstructive Pulmonary Disease

Intervention ^ICMJE

Drug: Bisoprolol
Titration. 1.25 mg 2 weeks, 2.5 mg 2 weeks, 5 mg 4 weeks, 7.5 mg 4 weeks, 10 mg 4 weeks.
Other Names:
- Bisoprolol Fumarate
- Brand name: Cardicor
Drug: Placebo
Titration. 1.25 mg 2 weeks, 2.5 mg 2 weeks, 5 mg 4 weeks, 7.5 mg 4 weeks, 10 mg 4 weeks.

Study Arm (s)

Experimental: 1
Bisoprolol

Intervention: Drug: Bisoprolol
Placebo Comparator: 2
Identical appearance matching placebo

Intervention: Drug: Placebo

Publications *

Hawkins NM, MacDonald MR, Petrie MC, Chalmers GW, Carter R, Dunn FG, McMurray JJ. Bisoprolol in patients with heart failure and moderate to severe chronic obstructive pulmonary disease: a randomized controlled trial. Eur J Heart Fail. 2009 Jul;11(7):684-90. Epub 2009 May 21.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

July 2008

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

symptomatic NYHA II or III chronic heart failure
left ventricular systolic dysfunction
moderate or severe chronic obstructive pulmonary disease
with or without significant reversibility

Exclusion Criteria:

beta−blocker contraindications
non−dihydropyridine (diltiazem / verapamil) calcium channel blockers
recent coronary percutaneous intervention or coronary artery bypass graft surgery
haemodynamically significant valvular disease or hypertrophic cardiomyopathy.
active myocarditis or pericarditis.
recent cerebrovascular accident or transient ischaemic attack
serious concurrent systemic disease, such as malignancy, resulting in likely reduced life expectancy
pregnancy, childbearing potential with inadequate contraception, breast feeding

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00702156

Other Study ID Numbers ^ICMJE

RN05CA013

Has Data Monitoring Committee

Yes

Responsible Party

Dr Nathaniel Hawkins, Glasgow Royal Infirmary

Study Sponsor ^ICMJE

NHS Greater Glasgow and Clyde

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Nathaniel M Hawkins, MBChB	NHS Greater Glasgow and Clyde
Study Chair:	Francis G Dunn, MBChB MD	NHS Greater Glasgow and Clyde
Study Director:	Roger Carter, BSc MSc PHD	NHS Greater Glasgow and Clyde
Study Director:	George W Chalmers, MBChB MD	NHS Greater Glasgow and Clyde

Information Provided By

NHS Greater Glasgow and Clyde

Verification Date

August 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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